SPG601 / Spinogenix - LARVOL DELTA

SPG601-associated modulation of resting-state EEG and improvement in executive function in a fragile X syndrome randomized controlled crossover study. (PubMed, Sci Rep) - "No significant effects were observed on auditory-evoked gamma measures. This study provides the first clinical evidence that SPG601 produces significant neurophysiological changes in FXS, accompanied by a cognitive enhancement in executive function."

Clinical • Journal • Autism Spectrum Disorder • Developmental Disorders • Fragile X Syndrome • Genetic Disorders • Mental Retardation

A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants (clinicaltrials.gov) - P2/3 | N=248 | Not yet recruiting | Sponsor: Spinogenix

New P2/3 trial • Fragile X Syndrome • Genetic Disorders

European Medicines Agency Grants Orphan Drug Designation to Spinogenix's SPG601 for Treatment of Fragile X Syndrome (FXS) (PRNewswire) - "Spinogenix, Inc...announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to SPG601 for the treatment of people with Fragile X syndrome (FXS), a condition for which there is currently no approved medicine....Dr. Erickson will present results from the Phase 2 trial at the Cincinnati Fragile X Family Conference, taking place on Saturday, July 12 at Cincinnati Children's Hospital."

Orphan drug • P2 data • Fragile X Syndrome

Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity (PRNewswire) - P2a | N=10 | NCT06413537 | Sponsor: Spinogenix | "Spinogenix...announced topline results from a Phase 2 study of its SPG601 therapy in adult men with Fragile X syndrome (FXS) (NCT06413537)...A primary goal of the study was to determine if SPG601 reduced high frequency gamma band activity, an abnormality seen in electroencephalogram (EEG) recordings of FXS patients that occurs at the expense of normal brain activity levels that are more for learning and memory. The Phase 2 trial met this goal with SPG601 significantly reducing high frequency gamma band activity in the FXS subjects....Spinogenix and Cincinnati Children's are completing analysis of the full study results in preparation for publication."

P2 data • Trial completion • Fragile X Syndrome

SPG601-01: Study of SPG601 in Adult Men With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Spinogenix | Recruiting ➔ Completed

Trial completion • Fragile X Syndrome • Genetic Disorders

SPG601-01: Study of SPG601 in Adult Men With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Spinogenix | Not yet recruiting ➔ Recruiting

Enrollment open • Fragile X Syndrome • Genetic Disorders

Spinogenix Announces U.S. FDA Orphan Drug Designation Granted to SPG601 for the Treatment of Fragile X Syndrome (GlobeNewswire) - "Spinogenix, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to SPG601 for the treatment of Fragile X Syndrome (FXS)."

Orphan drug • Fragile X Syndrome • Genetic Disorders

SPG601-01: Phase 2a Study of SPG601 in Adult Men With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Spinogenix

New P2 trial • Fragile X Syndrome • Genetic Disorders